LifeVest Post-CABG Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Zoll Medical Corporation
Sponsor:
Information provided by (Responsible Party):
Zoll Medical Corporation
ClinicalTrials.gov Identifier:
NCT01448005
First received: October 4, 2011
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

This is a multi-center prospective registry of patients with an ejection fraction (EF) ≤ 35% following coronary artery bypass graft (CABG) surgery in order to test the hypothesis that wearable defibrillators (WD) will decrease overall mortality after discharge by decreasing arrhythmic death in this select population with high risk for sudden cardiac death (SCD). This is a pilot project to determine the feasibility of a larger-scale study.


Condition Intervention
Sudden Cardiac Death
Ventricular Fibrillation
Ventricular Tachycardia
Ventricular Dysfunction
Myocardial Ischemia
Device: wearable defibrillator (LifeVest)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-market Release Registry of Wearable Defibrillator Use in Patients With Ventricular Dysfunction Following CABG Surgery

Resource links provided by NLM:


Further study details as provided by Zoll Medical Corporation:

Primary Outcome Measures:
  • number of patients who experience sudden cardiac death [ Time Frame: three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of patients who experience inappropriate shocks [ Time Frame: three months ] [ Designated as safety issue: Yes ]
  • hours per day of wearable defibrillator use [ Time Frame: three months ] [ Designated as safety issue: No ]
  • number of patients who experience sudden cardiac arrest [ Time Frame: three months ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: February 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
wearable defibrillator use
subjects will use a wearable defibrillator
Device: wearable defibrillator (LifeVest)
A wearable defibrillator automatically detects and treats ventricular tachycardia and ventricular fibrillation without the need for bystander intervention.
Other Names:
  • LifeVest
  • wearable cardioverter defibrillator
  • wearable automatic external defibrillator

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who have undergone CABG surgery during current hospitalization and have an ejection fraction ≤ 35% following the surgery.

Criteria

Inclusion Criteria:

  • Patients who have undergone CABG surgery during current hospitalization
  • Patients who have an ejection fraction ≤ 35% following the surgery.
  • Patients who have dilated cardiomyopathy or prior myocardial infarction.
  • Patients who are prescribed a wearable defibrillator following surgery.
  • Patient who are at least 18 years old.

Exclusion Criteria:

  • Patients who have an active ICD.
  • Patients who have an active unipolar pacemaker.
  • Patients having a chest circumference over 56 inches or under 26 inches.
  • Patients who are unable to consent or unwilling to wear the WCD after discharge or who do not agree to be contacted at 90 days.
  • Patients with a mental, visual, physical or auditory deficit that could impair their ability to properly interact with a wearable defibrillator.
  • Patients participating in another clinical study with mortality as the primary endpoint.
  • Patients unable to use a wearable defibrillator due to physical conditions (bandages preventing electrode contact, physical deformities preventing electrode contact, dextrocardia, etc.).
  • Patients who have decided to forgo resuscitation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448005

Contacts
Contact: Steven J Szymkiewicz, MD 412-968-3333 ext 4400 sszymkiewicz@zoll.com

Locations
United States, California
Sutter Heart and Vascular Institute Recruiting
Sacramento, California, United States, 95819
Contact: John Chin, MD    916-736-2323    jchin@rcamd.com   
Contact: Beverly Seiler, RN    916-733-8169    seilerb@sutterhealth.org   
Principal Investigator: John Chin, MD         
United States, Georgia
Saint Joseph's Health System, Inc. Recruiting
Atlanta, Georgia, United States, 30342
Contact: Jeffrey S Miller, MD    404-256-6104    jeffrey.miller@emoryhealthcare.org   
Contact: Michele Fielding, RN    678-843-6094    michele.fielding@emoryhealthcare.org   
Principal Investigator: Jeffrey S Miller, MD         
United States, Maryland
Washington Adventist Hospital Recruiting
Takoma Park, Maryland, United States, 20912
Contact: Sean C Beinart, MD    301-670-3000    sbeinart@gmail.com   
Contact: Melissa L Ramey, RN    301-891-5024    mramey2@adventisthealthcare.com   
Principal Investigator: Sean Beinart, MD         
Sub-Investigator: Anthony Rongione, MD         
Sub-Investigator: Paul Massimiano, MD         
United States, Texas
Texas Heart Institute, St. Luke's Episcopal Hospital Recruiting
Houston, Texas, United States, 77030
Contact: C. David Collard, MD    832-355-2666    ccollard@sleh.com   
Contact: Carliss Ramos, RN    832-355-8388    cramos@texasheart.org   
Principal Investigator: C. David Collard, MD         
Sub-Investigator: Wei Pan, MD         
United States, Virginia
Chippenham Johnston-Willis Medical Center Recruiting
Richmond, Virginia, United States, 23225
Contact: Thomas D Christopher, MD    804-320-2751    thomas.christopher@hcahealthcare.com   
Contact: Margaret T Wittenbraker, ACNP    804-320-2751    margaret.wittenbraker@hcahealthcare.com   
Principal Investigator: Thomas D Christopher, MD         
Sub-Investigator: Graham M Bundy, MD         
Sub-Investigator: Leo M Gazoni, MD         
Sub-Investigator: Dipin Gupta, MD, MBA         
Sub-Investigator: Chiwon Hahn, MD         
Sub-Investigator: Joseph J Zocco, MD         
Sponsors and Collaborators
Zoll Medical Corporation
Investigators
Study Director: Steven J Szymkiewicz, MD Zoll Medical Corporation
  More Information

No publications provided

Responsible Party: Zoll Medical Corporation
ClinicalTrials.gov Identifier: NCT01448005     History of Changes
Other Study ID Numbers: 90D0107
Study First Received: October 4, 2011
Last Updated: January 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Zoll Medical Corporation:
Coronary Artery Bypass Grafting
Resuscitation
Sudden Cardiac Death
Ventricular Dysfunction

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Death
Ischemia
Tachycardia
Ventricular Fibrillation
Tachycardia, Ventricular
Death, Sudden, Cardiac
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Arrhythmias, Cardiac
Heart Arrest
Death, Sudden

ClinicalTrials.gov processed this record on July 22, 2014